Circadian Rhythms and Homeostatic Sleep Drive and Their Effect on Reward and Cognitive Control Systems in Adolescents

Официальное название

Center for Adolescent Reward, Rhythms and Sleep Project 1

Обзор

Adolescence is a time of heightened reward sensitivity and greater impulsivity. On top of this, many teenagers experience chronic sleep deprivation and misalignment of their circadian rhythms due to biological shifts in their sleep/wake patterns paired with early school start times, which may increase the risk for substance use (SU). However, what impact circadian rhythm and sleep disruption either together or independently have on the neuronal circuitry that controls reward and cognition, or if there are interventions that might help to modify these disruptions is unknown. Project 1 (P1), specifically examines homeostatic and circadian characteristics as mechanisms linking habitual sleep patterns, reward and cognitive control (at subjective, behavioral, and circuit levels), and longitudinal substance use risk.

Подробное описание

P1 will study 200 adolescents ages 13-18 in a 48-h to 60-h laboratory study. Participants will monitor sleep patterns at home for 2 weeks with actigraphy and sleep diary, and will also complete fMRI measures of reward and cognitive control. This will be followed by a 48-to-60-hour laboratory visit. The laboratory session includes two nights of polysomnography (PSG) sleep studies (the second night of PSG was halted for all participants as of January 2026), separated by 28 h of an ultradian sleep/wake protocol-every 120-minutes, there will be an 80-minute period of waking, followed by a 40-minute sleep opportunity. (Prior to January 2026, participants had a 36-h ultradian sleep/wake protocol, which was then shortened to 28 hours). Participants will be in dim light conditions and temporal isolation for the first 28 h of the ultradian sleep/wake protocol. Physiological circadian measures include salivary melatonin; core body temperature (CBT); and molecular rhythms from hair follicle cells (examined in Project 3). Physiological sleep homeostatic measures include waking EEG theta power, slow-wave sleep rebound following the ultradian sleep/wake protocol (for participants enrolled prior to January 2026), and repeated sleep latency on the sleep opportunities. Behavioral tests (Reward Anti-Saccade task to index cognitive control with/without reward modulation; Psychomotor Vigilance Test) and self-reports of mood/sleepiness will be collected every 2 h. Longitudinal on-line surveys will assess substance use every 6 months for the life of the grant.

Вмешательства

• Поведенческое Ultradian sleep/wake protocol
  120-minute schedule, consisting of 80 minutes awake followed by a 40 minute sleep opportunity for up to 36 hours

Первичные конечные точки

• Change in EEG delta power across overnight polysomnography on the night preceding vs. following the 36-hour ultradian sleep/wake protocol. [Срок оценки: The first night of sleep preceding the 36-hour ultradian sleep/wake protocol vs the night of sleep following the ultradian sleep/wake protocol]
• Change in slope of waking EEG theta power [Срок оценки: Every 2 hours during the ultradian sleep/wake protocol, up two 36 hours]
• Melatonin onset [Срок оценки: The first 28-hours of the ultradian sleep/wake protocol]

Вторичные конечные точки (8)

• Circadian pattern of Core Body Temperature (CBT) [Срок оценки: Measured continuously across the ultradian sleep/wake protocol, up two 36 hours.]
• Melatonin amplitude [Срок оценки: Collected every 30-60 minutes across the ultradian sleep/wake protocol, up two 36 hours]
• Sleep latency [Срок оценки: During the 40-minute sleep opportunities collected every two hours across the ultradian sleep/wake protocol, up two 36 hours]
• Influence of sleep and circadian measures on neural correlates of impulse control [Срок оценки: Measures from the ultradian sleep/wake protocol in relation to an fMRI scan measured 1 to 2 weeks earlier.]
• Influence of sleep and circadian measures on neural correlates of reward anticipation and reward outcome. [Срок оценки: 1 to 2 weeks before to immediately after the ultradian sleep/wake protocol.]
• Performance on the Psychomotor Vigilance Task [Срок оценки: Collected every 2 hours during the ultradian sleep/wake protocol, up two 36 hours.]
• Performance on the Reward Anti-Saccade task [Срок оценки: Collected every two hours during the ultradian sleep/wake protocol, up two 36 hours.]
• Substance use [Срок оценки: Every 6 months for the duration of the study, up to 4.5 years]

Критерии участия

Критерии включения

• Age 13-18 years
• Currently enrolled in a traditional high-school (not cyber- or home-schooled) \[school closures during the COVID-19 pandemic are an exception to this\]
• Physically and psychiatrically healthy
• Provision of written informed consent and assent

Критерии исключения

• outside age range above
• have a history of alcohol, cannabis, or illicit drug use greater than weekly use in the past year
• have serious medical or neurological disorders, including history of seizures
• have serious psychiatric disorders (e.g. bipolar disorder and schizophrenia)
• taking antidepressants (SSRIs/SSNIs are OK) or medications known to impact sleep/wake function - some medications may be okay if willing and able to discontinue prior to and/or for laboratory procedures
• have sleep disorders other than insomnia or Delayed Sleep Phase Disorder
• have MRI contraindications (i.e., metal in the body; claustrophobia)
• first degree relative with bipolar disorder
• frequent headaches or migraines
• inability to swallow pills/capsules.
• pregnancy
• participants with observed Obstructive Sleep Apnea via Apnealink, as indicated by an Apnea Hypopnea Index (AHI) of greater than 5
• Less than 80 lbs. or a BMI of greater than 35

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Western Psychiatric Hospital — Pittsburgh

Идентификаторы

NCT: NCT05336084 · STUDY20030237 · P50DA046346

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗